FDA 510(k) Application Details - K243921

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K243921
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	Foshan COXO Medical Instrument Co., Ltd. No.17,Guangming Ave ,New Light Source Industrial Base, Nanha National High-tech Zone Foshan 528226 CN Other 510(k) Applications for this Company
Contact	Zhaorong Li Other 510(k) Applications for this Contact
Regulation Number	872.6070   More FDA Info for this Regulation Number
Classification Product Code	EBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2024
Decision Date	04/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review